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FDA approved Heparin Sodium in 0.45% Sodium Chloride Injection for Thromboembolic IndicationsFDA approved Premixed Blood Thinner Heparin for Intravenous Use in Hospitals

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Key Takeaway
Note this premixed heparin is IV infusion only, not a catheter lock flush, and titrate to APTT 1.5 to 2 times normal.

The FDA has approved Heparin Sodium in 0.45% Sodium Chloride Injection, a premixed intravenous heparin formulation, for a range of thromboembolic and anticoagulation indications. These include prophylaxis and treatment of venous thrombosis and pulmonary embolism, prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation, treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation), prevention of clotting in arterial and cardiac surgery, prophylaxis and treatment of peripheral arterial embolism, and anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.

Clinically, the label emphasizes that this product is for intravenous infusion only and must not be used as a catheter lock flush or admixed with other drugs. Dosing is weight-based and guided by coagulation testing, with dosage considered adequate when the APTT is 1.5 to 2 times normal or whole blood clotting time is elevated approximately 2.5 to 3 times control. Periodic platelet counts, hematocrits, and stool occult blood testing are recommended throughout therapy. Trial data not available in label.

+ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Not reported in label.

Indication & Patient Population

Heparin Sodium in 0.45% Sodium Chloride Injection is indicated for prophylaxis and treatment of venous thrombosis and pulmonary embolism; prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation; treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation); prevention of clotting in arterial and cardiac surgery; prophylaxis and treatment of peripheral arterial embolism; and anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. Pediatric dosing recommendations are based on clinical experience; there are no adequate and well-controlled studies in pediatric patients.

Dosing & Administration

Administer by intravenous infusion only. Do not use as a catheter lock flush. Do not admix with other drugs. Discard unused portion. Do not use plastic containers in series connection. Do not infuse under pressure. Inspect visually for particulate matter and discoloration; use only if solution is clear and container and seals are intact.

Adult full-dose therapeutic regimens (based on 150 lb/68 kg patient): intermittent IV injection with initial dose 10,000 Units, subsequent doses 5,000 to 10,000 Units every 4 to 6 hours; continuous IV infusion with initial dose 5,000 Units by IV injection, then 20,000 to 40,000 Units every 24 hours. Adjust dosage per coagulation test results. For continuous infusion, determine coagulation time approximately every 4 hours early in treatment; for intermittent injection, perform coagulation tests before each injection early in treatment and at appropriate intervals thereafter. Dosage is considered adequate when APTT is 1.5 to 2 times normal or whole blood clotting time is elevated approximately 2.5 to 3 times control. Periodic platelet counts, hematocrits, and stool occult blood tests are recommended during the entire course of therapy.

Cardiovascular surgery: initial dose not less than 150 units/kg for total body perfusion; frequently 300 units/kg for procedures estimated under 60 minutes or 400 units/kg for longer procedures. Extracorporeal dialysis: follow equipment manufacturer operating directions carefully.

Pediatric guideline: initial 75 to 100 units/kg IV bolus over 10 minutes; maintenance for infants 25 to 30 units/kg/hour (infants under 2 months have highest requirements, average 28 units/kg/hour); children over 1 year 18 to 20 units/kg/hour; older children may require less. Adjust to maintain APTT of 60 to 85 seconds, assuming this reflects anti-Factor Xa level of 0.35 to 0.70.

Converting to warfarin: continue full heparin therapy for several days until INR reaches a stable therapeutic range, then discontinue without tapering. Converting to oral anticoagulants other than warfarin: stop IV infusion immediately after first oral anticoagulant dose, or for intermittent IV administration start oral anticoagulant 0 to 2 hours before the next heparin dose.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

The FDA has approved a premixed version of heparin, a well known blood thinner, that is given through a vein. The product comes ready to use in a plastic container and is meant only for intravenous infusion in a healthcare setting.

It is approved to prevent and treat blood clots in the legs and lungs, to help people with an irregular heartbeat called atrial fibrillation avoid clot-related problems, and to treat certain clotting disorders. It is also used to prevent clotting during heart and artery surgery, in blood transfusions, and in dialysis.

Doctors adjust the dose based on each person's weight and on blood tests that show how well the blood is clotting. The label says patients should have platelet counts, blood counts, and stool tests checked during treatment. This approval means hospitals have another premixed option that may save time and reduce mixing errors.

One honest caveat: this is not a new medicine, and it is not for use at home or as a catheter flush. If you or a loved one needs heparin, talk with your doctor about the right form and dose for your situation.

What this means for you:
This is a ready-to-use hospital form of an existing blood thinner, not a new medicine for home use.

Study Details

Study typeFda approval
PublishedJul 1992
View Original Abstract ↓
1 INDICATIONS AND USAGE Heparin Sodium in 0.45% Sodium Chloride Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism; Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation; Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and cardiac surgery; Prophylaxis and treatment of peripheral arterial embolism; Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. Heparin sodium is indicated for: (1) Prophylaxis and treatment of venous thrombosis and pulmonary embolism; Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation; Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and cardiac surgery; Prophylaxis and treatment of peripheral arterial embolism; Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
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